MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE PRO FLASH GLUCOSE MONITORING SYSTEM

Model Number 71562-01

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/30/2019

Event Type  Injury  

Manufacturer Narrative

The product has been requested back for an investigation. A follow-up report will be submitted once additional information is obtained. The date of event is unknown. The date entered is the date abbott diabetes care became aware of the event. The device mfg date is unknown. The date entered is the date abbott diabetes care became aware of the event. All pertinent information available to abbott diabetes care has been submitted.

Event Description

A healthcare profession called to report that customer experiencing pain and upon removal of the freestyle libre pro sensor, it was noticed that portion of the filament had broken and left in the customer¿s body which required medical intervention. A surgical procedure was performed to remove the filament and no further treatment was reported. There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Sensor (b)(4) has been returned and investigated. Performed visual inspection on the returned sensor patch and no issues were observed. Observed that the sensor plug was fully seated. Observed that the sensor tail was severed. Removed plug and inspected plug assembly; no failure mode was observed. Extended investigation has also been performed. Performed a visual inspection on the returned product and observed the sensor tail to be severed. While the sensor tail was observed to be broken, investigation of the complaint determined that there was no indication that the product did not meet specification. Sensor measurements and tripped trend review for the returned sensor¿s lot was conducted and there were no anomalies identified. Due to the in process quality checks, the severed tail could only have been sustained upon removal from the user. No other damage was observed during visual inspection of the internal components of the puck. A simvivo test was performed and the returned puck passed, indicating that the electronics were functioning properly. As there is no evidence of a product malfunction, this complaint is not confirmed. The device mfg date is unknown. The date entered i is the date abbott diabetes care became aware of the event. All pertinent information available to abbott diabetes care has been submitted. Device was returned and investigation was performed.

Event Description

A healthcare profession called to report that customer experiencing pain and upon removal of the freestyle libre pro sensor, it was noticed that portion of the filament had broken and left in the customer¿s body which required medical intervention. A surgical procedure was performed to remove the filament and no further treatment was reported. There was no report of death or permanent impairment associated with this event.

• Brand Name: FREESTYLE LIBRE PRO
• Type of Device: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• MDR Report Key: 9214113
• Report Number: 2954323-2019-08137
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• PMA/PMN Number: P150021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 71562-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Outcome(s): Required Intervention